Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

Phase 3

Recruiting

• Conditions: Neurotrophic Keratopathy
• Interventions: Drug: Placebo; Drug: RGN-259

• Registration Number: NCT05555589
• Lead Sponsor: ReGenTree, LLC

Brief Summary

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Detailed Description

Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2023-04-11
• Status Verified: 2023-06
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-07-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)	Placebo	It is composed of the same excipients as RGN-259 but does not contain Tβ4
0.1% RGN-259 Opthalmic Solution	RGN-259	It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days

Primary Outcome Measures

Name	Time	Method
Percentage of subjects achieving complete healing of PED at Day 29	Day 29	Percentage of subjects achieving complete healing of the Persistent Epithelial Defect (PED) at Day 29 determined by corneal fluorescein staining as measured by the Central Reading Center.

Secondary Outcome Measures

Name	Time	Method
Visual Acuity determined by ETDRS	Day 8, 15, 22, 29, 36, and 43	Visual Acuity determined by Early Treatment of Diabetic Retinopathy Study (ETDRS)
NK stage by Mackie classification	Day 8, 15, 22, 29, 36, and 43	NK stage graded according to the Mackie classification (Stage I, II, III. Higher scores mean a better or worse outcome)
Corneal sensitivity inside the lesion determined by Cochet Bonnet aesthesiometer (Unit: mm)	Day 8, 15, 22, 29, 36, and 43
Percentage of subjects achieving complete healing of PED at Day 29	Day 29	Percentage of subjects achieving complete healing of the PED determined by corneal fluorescein staining as measured by the Investigator.
Percentage change from baseline of lesion size	Day 8, 15, 22, 29, 36, and 43	Percentage change from baseline of lesion size determined by corneal fluorescein staining (measurements of greatest dimension of fluorescein staining)

Trial Locations

Locations (33)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

Loma Linda University Eye Institute; 🇺🇸 Loma Linda, California, United States

Nvision Clinical Research, LLC.; 🇺🇸 Los Angeles, California, United States

Dr. Shultz and Dr. Chan; 🇺🇸 Northridge, California, United States

Retina Consultants of Southern Colorado; 🇺🇸 Colorado Springs, Colorado, United States

Advance Vision Research Institute; 🇺🇸 Longmont, Colorado, United States

Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons; 🇺🇸 Danbury, Connecticut, United States

University of Miami; 🇺🇸 Coral Gables, Florida, United States

University of South Florida, Ophthalmolgoy; 🇺🇸 Tampa, Florida, United States

Thomas Eye Group, P.C.; 🇺🇸 Sandy Springs, Georgia, United States

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